This blog began in 2007, focusing on anthrax vaccine, and later expanded to other public health and political issues. The blog links to media reports, medical literature, official documents and other materials.

Sunday, October 28, 2012

The Globe updates us on the NECC tragedy/scandal.
The outbreak of fungal meningitis due to contaminated drugs from New England Compounding Center brings to mind a 1997 FDA inspection and report of the Lansing, Michigan anthrax vaccine manufacturer, which at that time was a state of Michigan subsidiary: Michigan Biologic Products Institute. Many of the same types of manufacturing failures were noted then as seen now in Framingham, MA:

visible particulates (that looked like mold) were seen in vaccine vials from some lots

the manufacturer failed to test product lots as specified by FDA regulations

widespread failures of sterility tests were seen when performed by FDA--whereas when they had been performed by the manufacturer the vials had passed

mold was growing in rooms used for product manufacture

processes that were used to guarantee sterility, even if performed correctly, were probably not effective

And from just this one manufacturing facility, 338 life-threatening infections and 25 deaths have been identified.

It is uncertain how many people were damaged by poorly manufactured anthrax vaccine. What we do know is that the manufacturing facility for anthrax vaccine, which was owned by the state of Michigan with federally supplied equipment and oversight by US Army inspectors, chose to bulldoze the entire anthrax manufacturing facility shortly after the inspection.

“The FDA’s regulatory authority over compounding pharmacies is limited by law. Because of these limitations, compounded drugs are not FDA-approved for safety and efficacy, and compounding pharmacies are not generally required to tell the agency what products they are making,” she wrote in a USA Today opinion piece. “The FDA’s authority to inspect compounders’ records is also limited. Each compounding pharmacy is licensed by its state’s board of pharmacy, which has primary day-to-day oversight.”

After swimming with dolphins at Key Largo, they checked me out at the edge of the pool

Visiting a Bhutanese Dzong, the regional seat of both government and religion (and a fort for good measure)

Why am I blogging?

Because life is meant to be lived! The left side of this blog has photos of some peak experiences. And the right side contains information about which I am passionate.

Too many peoples' lives are characterized by lack of authenticity, and fear of acknowledging and expressing their true nature. Employees cannot say what they think at work, and in the corporate system we must squish ourselves into square holes when we are round pegs. We thus lose touch with our souls, becoming cogs in a soulless, profit-driven machine.

The culture of political correctness has meant, in medicine, that we ignore how the foundations of our science are being undermined by commercialism. Clinical data generated or presented by the manufacturers of drugs, vaccines and devices cannot be trusted: there are hundreds of studies proving this. But this fraudulent information continues to be the only data informing the approval of vaccines, drugs and devices.

Unless scrupulous ethical conduct is demanded of physicians and biological scientists, our lack of meaningful standards will carry the medical-pharmaceutical system down the path of increasing irrelevance.

Medicine and its tools need to be affordable. The current medical-industrial milieu, characterized by contempt for science, countless ways for insiders to achieve wealth due to failure of good governance, and regulatory agency-to-industry revolving doors, has ushered in stratospheric pricing... further kicking us down that path to irrelevance.

Why is our new health care plan a giveaway to health industries instead of to health consumers? Why won't it cover all Americans? Why was the "public option" never an option for the Obama administration? Why did the promised Trump health plan evaporate the moment he was elected?

So many of our leaders carry a heavy burden of mendacity and avarice. If they instead got in touch with their own souls (perhaps by exposure to the natural world), or made their decisions by maximizing the amount of good that results, our leaders might find real meaning and value in their lives.

Until that happens, the only way to straighten out the current mess is to demand accountability and impose penalties on unethical/dishonest leaders. Both political parties enjoy bounteous hors d'oeuvres from Pharma's table, making it unlikely the existing political "process" will provide relief--as we've seen in the demoralizing healthcare reform drama.

Until then, I'll continue to "call it as I see it" in this blog -- working and living the way life should be, in rural Maine, far from the centers of power.

Ellen Byrne has created several designs encapsulating aspects of the FBI's ridiculous case against Bruce Ivins. They can be purchased on T-shirts and coffee mugs. All proceeds will be donated to the the Frederick County chapter of the American Red Cross, a favored charity of Dr. Bruce Ivins.